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DRAP RECALL ALERT JUNE 2025

DRAP Recall Alert⚠️Recall of Substandard “Tovir 0.5mg Tablet” having Batch No. 55, Manufactured by M/s Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi.

Drap alert no: NI/S/06-25-46

Product: Tovir 0.5 mg Tablet (Clonazepam 0.5 mg)

Batch: No. 55

Manufacturer: M/s Adamjee Pharmaceuticals (Pvt.) Ltd., No. 39 sector 15 korangi  industrial area, Karachi.

Date of DRAP’s Recall: 17 June 2025

Reason of Recall: Identified as substandard due to failure in content-uniformity testing by the federal analytical lab (CDL Karachi) .

Risks of Administration of Recalled Tablets: Use of this substandard clonazepam tablet may lead to therapeutic failure, especially affecting immunocompromised individuals, children, and the elderly .

Actions Taken by DRAP:

  • DRAP and provincial drug control agencies have ordered immediate market withdrawal and recall of the affected batch 

  • Pharmacies and distributors are instructed to quarantine any stock of batch 55 and return it to the supplier.

Advice:

  • Healthcare professionals should monitor their supply chains, watch for adverse events, and report any issues to DRAP’s National Pharmacovigilance Centre via Adverse effect reporting forms or Vigimobile App

  • Consumers with the affected batch are urged to stop using it immediately, consult their physician, and report any problems experienced.

 

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Reference:

Drug Regulatory Authority of Pakistan. (2025, June 19). Recall alert: Recall of substandard Tovir 0.5 mg tablet (Batch No. 55) manufactured by M/s Adamjee Pharmaceuticals (Pvt.) Ltd. Karachi. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-recall-of-substandard-tovir-0-5mg-tablet-batch-no-55-manufactured-by-m-s-adamjee-pharmaceuticals-pvt-ltd-karachi/

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